No, I'm not saying anything other than the President and lead researcher has stated the end of the fiscal year as a goal for filing for a pre-IND meeting.
One of the biggest issues right now is the ramifications of the FDA overhaul in 2005, which formally established the pre-IND meeting and was aimed at bringing new technologies and novel drugs to market. The website outlining the process and procedure for the pre-IND was only create in 2009 and has been greatly modified and expanded since then. IMO, the net effect of the 2005 changes has been to make the path more difficult by adding a new layer of almost mandatory review ahead of the INDA review.
I can't imagine any novel drug developer even considering not doing a pre-IND ahead of filing the INDA. The rules and procedures change almost yearly and without guidance in writing a company today sets itself up for rejection if it does not hold a copy of that pre-IND review and comments.
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